Estimate the Safety and Effectiveness of Adjuvanted Influenza Vaccine Among Asian Elderly People When Compared to Non-adjuvanted Vaccines

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare two types of seasonal influenza vaccines in older adults, specifically those aged 65 and older who have chronic health issues. The study will look at how well the adjuvanted influenza vaccine (which has an added ingredient to boost the immune response) works compared to a standard, non-adjuvanted vaccine. Researchers want to understand which vaccine helps the immune system better and how safe each one is for this population, especially since older adults are at a higher risk of facing complications from influenza.

To be eligible for this trial, participants must be 65 years or older and have at least one chronic medical condition, such as diabetes, heart disease, or lung diseases like asthma. However, people who have had severe reactions to vaccines in the past, those who have already received a flu vaccine this season, or those deemed ineligible by the study staff will not be able to participate. While the study is not actively recruiting participants yet, those who join can expect to receive either vaccine and will be monitored for any side effects. This trial is important as it aims to improve flu vaccination strategies for older adults, helping ensure they stay healthy during flu season.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 65 years or above
• • Presence of at least 1 chronic medical condition associated with increased risk of complicated influenza, including hypertension, chronic obstructive pulmonary disease (group A, B, E), asthma, congestive heart failure (ACC/AHA stage A, B, C, D), coronary arterial disease, diabetes mellitus, chronic liver disease (Child-Pugh score A, B, C) or chronic kidney disease (stage 1\~4), neuromuscular disorders, hematological or solid organ malignancies, recipient of hematopoietic stem cell transplantation or solid organ transplantation.
• Exclusion Criteria:
• • Contraindications to influenza vaccination including history of severe adverse event after vaccination, such as anaphylaxis or Guillain-Barré Syndrome, or a severe bleeding tendency
• • Prior receipt of influenza vaccination during the current flu season.
• • Determination by the Principal Investigator (PI) that the participant is ineligible for enrollment based on clinical assessment.